AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: caused by beta‑lactamase–producing isolates of Haemophilus  influenzae and Moraxella catarrhalis . caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . caused by beta‑lacta

Product summary:

Tablets Amoxicillin and clavulanate potassium tablets, USP 500 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, debossed with 500/125 on one side and AMC on the other side. They are supplied in plastic bottles of 20 and 100 (with desiccant) as under: NDC 66685-1002-0 bottles of 20 tablets NDC 66685-1002-2 bottles of 100 tablets Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, scored and debossed with 875/125 on one side and AMC on the other side. They are supplied in plastic bottles of 20 and 100 (with desiccant) as under: NDC 66685-1001-0 bottles of 20 tablets NDC 66685-1001-1 bottles of 100 tablets Oral Suspension Amoxicillin and clavulanate potassium for oral suspension, USP 200 mg/28.5 mg per 5 mL (each 5 mL of reconstituted caramel-orange-raspberry-flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt) are supplied as under: NDC 66685-1011-0 50 mL bottle NDC 66685-1011-1 75 mL bottle NDC 66685-1011-2 100 mL bottle Amoxicillin and clavulanate potassium for oral suspension, USP 400 mg/57 mg per 5 mL (each 5 mL of reconstituted caramel-orange-raspberry-flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt) are supplied as under: NDC 66685-1012-0 50 mL bottle NDC 66685-1012-1 75 mL bottle NDC 66685-1012-2 100 mL bottle Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
REMEDYREPACK INC.
REFERENCE LABEL SET ID: B6583123-8297-4EB9-AD0F-B074F8707683
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND CLAVULANATE POTASSIUM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND
CLAVULANATE POTASSIUM.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP AND FOR ORAL
SUSPENSION USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1984
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF AMOXICILLIN AND
CLAVULANATE POTASSIUM AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN AND
CLAVULANATE POTASSIUM SHOULD BE USED
ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE
CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium is a combination
penicillin-class antibacterial and beta lactamase inhibitor indicated
for treatment of the following:
Lower respiratory tract infections (( 1.1)
Acute bacterial otitis media (( 1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
DOSAGE AND ADMINISTRATION
Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours or
250 or 500 mg every 8 hours. ( 2.1, 2.2)
Pediatric patients aged 12 weeks (3 months) and older: 25 to 45
mg/kg/day every 12 hours or 20 to 40 mg/kg/day every
8 hours, up to the adult dose. (2.2)
Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every 12
hours, based on the amoxicillin component.
Use of the 125 mg/5 mL oral suspension is recommended. (2.2)
DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin and clavulanate content are:
Tablets: 500 mg/125 mg, 875 mg/125 mg. (3)
Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to amoxicillin and
clavulanate potassium or to other beta lactams (e.g., penic